[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542919":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":52,"locations":30,"responsibleParty":58,"collaborators":30,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":30,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":83,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":30},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Screen-and-Treat Strategy","EXPERIMENTAL","Patients are systematically screened for BV before 18 weeks' gestation by means of a vaginal swab analyzed by the innovative technique, whose result will be disclosed. If positive, appropriate treatment will be prescribed.",[13,14,15,16,17],"Diagnostic Test: Vaginal flora abnormalities screening and quantification using molecular biology technique","Drug: Azithromycine","Drug: Ceftriaxone","Drug: Metronidazole","Drug: Clotrimazole, Vaginal",{"label":19,"type":20,"description":21,"interventionNames":22},"Group B: Control Group\u002FUsual Care or Standard Strategy","ACTIVE_COMPARATOR","Patients are not systematically screened for BV \u002Fusual care group.",[23],"Other: Usual Care",[25,31,36,40,44,48],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","Vaginal flora abnormalities screening and quantification using molecular biology technique","Vaginal self-sampling is a simple and validated method of sampling used for the molecular biology technique and the quantification of microorganisms involved in vaginal flora imbalance bacteriosis.The patient performs a self-sampling with a cotton swab transferred into a transport medium tube. The sample is sent to the laboratory where Multiplex Point of Care polymerase chain reaction (PCR) is performed.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Azithromycine","In case of Chlamydia trachomatis infections, as well as significant increase of Fannyhessea vaginae: 1 g per os in a single dose; In case of Neisseria gonorrhoeae infection: 2 g per os in a single dose (associated to ceftriaxone 1g IM)",[9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Ceftriaxone","In case of Neisseria gonorrhoeae infections, 1g, associated to azithromycin 2 g per os in a single dose",[9],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":30},"Metronidazole","Metronidazole ovules: In case of Trichomonas vaginalis infection during the 1st trimester of pregnancy: 1 ovule morning and evening for 14 days (French Society of Dermatology Recommendations 2016); Metronidazole 500 mg tablets in case of Trichomonas vaginalis infection during the 2nd or the 3rd trimester of pregnancy in a single dose of 2 g",[9],{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Clotrimazole, Vaginal","In case of Candida albicans infection in a single dose to be repeated up to 6 times if necessary.",[9],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"Usual Care","Patients will not be screened using molecular biology techniques in this group. The management of these patients is a matter of routine for health professionals. They will be free to prescribe a standard vaginal swab if symptoms are present and to treat their patients according to their usual protocols. No routine sampling is recommended in the absence of a history",[19],[53],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"Franceline CARTIER","CONTACT","+33491381927","promotion.interne@ap-hm.fr",{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100542919","phase-4-screen-and-treat-strategy-for-vaginal-flora-abnormalities-in-pregnant-women-at-high-risk-of-preterm-birth-100542919",false,"NCT06349122","Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth","Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2)","AUTOP2","Inclusion Criteria:\n\n* Pregnant women over 18 years of age\n* Pregnant woman after 8 weeks and before 18 weeks of gestation (i.e. \\>=8 weeks and ≤ 18 weeks)\n* Woman who has understood the study process and objectives and agreed to sign an informed consent form;\n* With a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population) (A late miscarriage or late fetal loss mean foetal loss between 14 and 22 weeks of gestation)\n* Affiliated to a social security regimen or equivalent\n\nExclusion Criteria:\n\n* \\- Woman of legal age under legal protection;\n* Women deprived of their freedom for administrative or legal reasons;\n* Woman who has not signed a consent form\n* Nulliparous;\n* Ectopic pregnancy;\n* Non-evolutive pregnancy or IUFD\n* Multiple pregnancy\n* Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly.\n* Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study\n* Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients\n* Woman presenting uterine malformation ( unicornuate, bicornuate, full septate)\n* Woman with preterm birth history because of twin pregnancy\n* Woman having received anti-infective treatment in the week preceding inclusion","FEMALE","18 Years",{"count":71,"type":72},1292,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.\n\nThe main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.\n\nThe hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.",[78,79,80],"Bacterial Vaginosis","Vaginal Dysbiosis","Premature Delivery",[82],"screen and treat strategy","NOT_YET_RECRUITING","2024-03-29",{"date":86,"type":87},"2024-04-05","ACTUAL",{"date":89,"type":72},"2024-08",{"date":91,"type":72},"2028-01",{"name":5,"class":6}]